A study presented Sunday at the 35th annual VEITHsymposium in New York suggests that the use of thrombolytic drug therapy along with Ekos' (Bothell, Washington) device designed to accelerate the dissolution of vascular blood clots is more effective at treating vascular thrombosis than standard non-ultrasound catheter directed thrombolysis (CDT). According to the data, Ekos-treated patients received half the thrombolytic drug dose or were treated in half the time, or both, when compared to standard non-ultrasound CDT.
By Friday, Ekos President/CEO Bob Hubert's voice was nearly hoarse from talking for three days at the VEITHsymposium about the company's technology for the treatment of vascular thrombosis. The Ekos booth was busy, Hubert told Medical Device Daily during a phone interview from the conference. But, "Busy is good, especially in this [economic] environment," he said.
Ekos says its MicroSonic Accelerated Thrombolysis (MSAT) is designed to provide faster, safer and more complete dissolution of thrombus. Hubert said the American College of Chest Physicians (Northbrook, Illinois) recently updated guidelines to suggest the use of thrombolytic drug therapy along with devices that accelerate the dissolution of vascular blood clots.
Ekos' infusion system is embedded with miniature ultrasound devices that pulse to open up the clot, making it more porous so the drug is absorbed into the clot, Hubert said, and the clot dissolves more readily. He likened the system to melting ice with water. If you take an ice cube and make it into a snow cone and drip water over it, the ice will melt faster than if you dripped water over the same ice cube before breaking it up into a snow cone, he said.
Karthikeshwar Kasirajan, MD, assistant professor of surgery at Emory University School of Medicine (Atlanta), presented data Sunday on 37 patients treated with catheter-direct pharmacological thrombolysis using recombinant tissue plasminogen activator (tPA) via the Ekos infusion system. The study, conducted from December 2006 to August 2008, showed that Ekos-treated patients received half the thrombolytic drug dose or were treated in half the time, or both, when compared to standard non-ultrasound CDT, the company noted. The purpose of the study was to evaluate the safety and efficacy of ultrasound as an adjunct to facilitate pharmacological thrombolysis.
Hubert noted that Kasirajan's study was generated using the company's first generation product. Its newest product, the EkoSonic Mach 4, was released in July and was showcased at the VEITHsymposium. He said the company already has installed 100 units of the new system and has received positive feedback to it.
Although the company has pegged the latest version of its product to be twice as fast as the first-generation device – making it four times faster than standard catheters – Hubert told MDD it looks as though the Mach 4 may actually exceed that.
Deep vein thrombosis (DVT) is a significant clot in the leg that affects more than 600,000 Americans a year, Hubert said, and a lot of those patients who are treated with drug regimen only end up with post-thrombotic syndrome (PTS), he added.
PTS develops as a result of damage to the venous valves when exposed to the occluding blood clot for more than a few weeks. The condition can subsequently develop over months or years into a serious irreversible debilitating condition, Ekos said. Thus, many physicians are now performing interventional treatments, such as the Ekos procedure, to remove as much of the clot as possible immediately after diagnosis of significant DVT.
"Using the Mach 4, we already have case reports of complete DVT resolution in less than six hours. The Mach 4, like our earlier-generation product, often dissolves clot out to the vessel wall including clot formed behind the valves. Unlike mechanical devices, the Ekos products have a high percentage of complete thrombus resolution, do not create hemolysis and present a low risk of distal embolization," Hubert said. "Clearly Ekos is setting a new standard of clot removal in the peripheral vasculature."
Competing systems are considered mechanical devices, he said, because they use a mechanical action designed to whip or beat the clot into tiny fragments, a violate action that can cause hemolysis, he noted. "A couple of the companies [that make mechanical devices] actually have timers on their system because ... there is a limit and a time that you can use some of these products."
During a phone interview with MDD on Friday, two days before his presentation, Kasirajan said he expected a positive response to the data. "I think people will be very happy to see there is something they can use with these clot busters with probably a much lower complication rate," he said.
From his experience using the Ekos product, Kasirajan said the device seems to make a big difference in terms of the speed at which a clot is dissolved and also in reducing the dose of drugs being used.
He also pointed out that the Ekos device doesn't really change the procedure, as far as the patient is concerned, and is similar to the catheter used to deliver the drugs. It also doesn't require the physician to learn anything new, Kasirajan said.